This year, GMTCC is fully part of the MedTech Forum. By joining forces to build synergies between the business and compliance communities, the industry is sending a clear message: compliance is part of the business!
I have always been in favour of having the compliance officer seen as a true business partner. Indeed, compliance programmes are not just a set of rules and policies drafted by an army of lawyers. On the contrary! A compliance programme will only be effective if it’s designed strategically by taking into account how the business is structured and what are the areas of risk. To be successful compliance must be embedded in the business activities. By adopting this common agenda, the medical device industry is leading by example, which is the right thing to do.
Actually, the real surprise would have been if the industry had taken any other approach. This year, again, there were several scandals involving our industry. First of all, the Implant Files. This investigation conducted by a consortium of independent journalists around the world tried to denounce the fact that some medical devices (implants in particular) were improperly put on the market and abusively prescribed by certain HCP.The investigation received a lot of media attention but none of these allegations finally revealed illegal behaviours from the medical device companies.
The healthcare system is certainly not perfect and further transparency shall be encouraged, in particular in the system of complaints reporting. It will be the case with the implementation of the Medical Device Regulation as from May 2020. But it should not be forgotten that the medical device industry is not the sole player in the health system and healthcare professionals and healthcare organizations have some responsibilities as well.
In the future, the main risk in terms of compliance will certainly come from new technologies and the way artificial intelligence (AI) is used to establish a diagnosis or to treat a patient. The type of data collected, the way the algorithms are coded and the predictability with which they will be used by the physicians will have a material impact on our healthcare system.
In addition, the majority of the most advanced players in this new system are not part of our industry. This is a new word which is hard to decrypt for most of us and we just start to consider the ethical issues that it could raise. It will require a lot of vision and managerial courage from our leaders to ensure that whatever technologies are used, the quality of our devices and the interest of the patient will continue to be our soles drivers.
This blog is part of the MedTech Forum blog series. Anne-Sophie Bricca will be speaking at the MedTech Forum. You can follow the conversation under #MTF2019 and find more details at medtechforum.eu.